Antiviral treatment of chronic hepatitis C in clinical routine.

OBJECTIVE Pegylated interferon plus ribavirin is the standard treatment for chronic hepatitis C. Sustained virological response (SVR) rates of up to 60% are reported in randomized controlled trials, but it is unclear whether the results from such trials are reproducible in the clinical routine setting. We investigated consecutive treatment-naïve chronic hepatitis C patients at our center to examine the efficacy of treatment with pegylated interferon plus ribavirin in clinical routine. MATERIALS AND METHODS Between 2000 and 2006 we treated a total of 219 patients with pegylated interferon alpha (2a or 2b) and ribavirin (800-1200 mg/d). Among them, 34.8% of patients infected with HCV genotypes 1/4/6 and 18.4% of those with genotypes 2/3 had advanced fibrosis or cirrhosis (F3-F4). For analysis of outcome we subdivided our series into two groups of patients: those who fulfilled standard inclusion criteria in randomized controlled trials and those who did not. RESULTS The overall SVR rate was 44.3%. In patients with F0-F2 an SVR was achieved in 52.5%; in those with F3-F4 the SVR rate was 20.8%. In patients infected with genotypes 1/4/6 the SVR rate was 35.4% (SVR: F0-F2 47.7%; F3-F4 19.6%); in those with genotypes 2/3 the rate was 67.8%. The SVR rate in patients with unfavorable baseline factors was significantly lower (32.4% vs. 50%; P = 0.017) and they were more likely to be non-responders (30.9% vs. 13.8%). CONCLUSION In everyday clinical practice, up to one-third of patients show unfavorable baseline factors for antiviral therapy, resulting in worse therapeutic outcome. Differences in therapeutic outcome are influenced by patient selection and by the proportion and severity of the underlying liver disease.